U-Systems, a provider of automated breast ultrasound technology, has received the Health Canada approval for its Somo V Automated Breast Ultrasound (ABUS) system as an adjunct to mammography to screen asymptomatic breast cancer in women.
The approval was based on the clinical evidence that the ABUS ultrasound device aids physicians with an increase in the sensitivity of breast cancer detection in diagnostic symptomatic and screening asymptomatic women.
The ABUS system uses proprietary technology to automate the breast ultrasound imaging process and is suited for the high-volume, screening environment.
The Somo viewer 3D Workstation enables fast review and archive of patient exams, optimising breast ultrasound screening workflow.
The ABUS is the only ultrasound device approved for breast cancer screening in the 27 EU countries, while in the US, the system is cleared by the Food & Drug Administration (FDA) for adjunctive diagnostic use with mammography, the company claims.
